Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiff

FDA device recall Z-2917-2026 · posted 2026-08-07 · Open, Classified

Recall details

Recalling firm

Galt Medical Corporation

Reason for recall

Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.

Action taken

On July 30, 2026, Galt Medical Issued a 4th iteration of the Urgent: Medical Device Recall Notification via Email expanding the affected lots. The initial notification was issued on June 26, 2026 via Email, 2nd notification issued on June 30, 2026 and 3rd notification issued on July 9, 2026. Galt Medical asked consignees to take the following actions 1. Discontinue use and distribution of the products with the affected lot numbers. 2. Examine your inventory, remove, and quarantine any identified devices with the affected lot numbers. 3. Ensure all applicable personnel within the vicinity of device activation carefully read the content of this notification. If affected product has been transferred to a different location, please ensure that location and personnel receive a copy of this notification 4. Complete the enclosed Field Correction Reply Forms and email or fax them to the attention of the Corrections Coordinator at quality@galtmedical.com or 214-778-1433. 5. For additional details, see recall notification.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

DQX

Quantity affected

114,260 kits

Distribution

US Nationwide distribution in the state of MN.

Date initiated

2026-06-26

Date posted

2026-08-07

Location

Garland, TX

Related 510(k) clearances